Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Post-Traumatic Stress Disorder | Study protocol

Trauma-focused therapies for post-traumatic stress in psychosis: study protocol for the RE.PROCESS randomized controlled trial

Authors: Simone R. Burger, Tineke van der Linden, Amy Hardy, Paul de Bont, Berber van der Vleugel, Anton B. P. Staring, Carlijn de Roos, Catherine van Zelst, Jennifer D. Gottlieb, Kim T. Mueser, Agnes van Minnen, Ad de Jongh, Machteld Marcelis, Mark van der Gaag, David van den Berg

Published in: Trials | Issue 1/2022

Login to get access

Abstract

Introduction

Many people with psychotic disorders experience symptoms of post-traumatic stress disorder (PTSD). In recent years, several trauma-focused therapies (TFTs), including cognitive restructuring (CR), prolonged exposure (PE), and eye movement desensitization and reprocessing (EMDR) have been studied and found to be safe and effective in reducing PTSD symptoms in individuals with psychosis. However, studies were conducted in different countries, with varying inclusion criteria, therapy duration, control groups, and trial outcomes. RE.PROCESS will be the first study to compare the impact of CR, PE, and EMDR with a waiting list control condition within the same context.

Methods and analysis

This is the protocol of a pragmatic, single-blind, multicentre, superiority randomized controlled trial, in which CR, PE, and EMDR are compared to a waiting list control condition for TFT (WL) in a naturalistic treatment setting. Inclusion criteria are as follows: age ≥ 16 years; meeting full DSM-5 diagnostic criteria for PTSD on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), with a total CAPS score ≥ 23; and a psychotic disorder in the schizophrenia spectrum confirmed by the Structured Clinical Interview for DSM-5 (SCID-5). Participants (N=200) will be randomly allocated to 16 sessions of one of the TFTs or WL, in addition to receiving treatment as usual (TAU) for psychosis. The primary objective is to compare the effects of CR, PE, and EMDR to WL on researcher-rated severity of PTSD symptoms over time from baseline to 6-month follow-up. Secondary objectives are to examine these effects at the separate time-points (i.e., mid-treatment, post-treatment, and at 6-month follow-up) and to test the effects for clinician-rated presence of PTSD diagnosis, and self-rated severity of (complex) PTSD symptoms.

Discussion

This is the first RCT to directly compare the effects of CR, PE, and EMDR within the same context to TAU on PTSD symptoms in individuals with psychosis and PTSD. Secondary effects on clinical and functional outcomes will be investigated both directly after therapy and long term.

Trial registration

ISRCTN ISRCTN56150327. Registered 18 June 2019.
Appendix
Available only for authorised users
Literature
1.
Matheson SL, Shepherd AM, Pinchbeck RM, Laurens KR, Carr VJ. Childhood adversity in schizophrenia: a systematic meta-analysis. Psychol Med. 2013;43(2):225–38.PubMedCrossRef
2.
Varese F, Smeets F, Drukker M, Lieverse R, Lataster T, Viechtbauer W, et al. Childhood adversities increase the risk of psychosis: a meta-analysis of patient-control, prospective- and cross-sectional cohort studies. Schizophr Bull. 2012;38(4):661–71.PubMedPubMedCentralCrossRef
3.
Bjorkenstam E, Burstrom B, Vinnerljung B, Kosidou K. Childhood adversity and psychiatric disorder in young adulthood: an analysis of 107,704 Swedes. J Psychiatr Res. 2016;77:67–75.PubMedCrossRef
4.
Trotta A, Murray RM, Fisher HL. The impact of childhood adversity on the persistence of psychotic symptoms: a systematic review and meta-analysis. Psychol Med. 2015;45(12):2481–98.PubMedCrossRef
5.
Maniglio R. Significance, nature, and direction of the association between child sexual abuse and conduct disorder: a systematic review. Trauma Violence Abuse. 2015;16(3):241–57.PubMedCrossRef
6.
Kamperman AM, Henrichs J, Bogaerts S, Lesaffre EM, Wierdsma AI, Ghauharali RR, et al. Criminal victimisation in people with severe mental illness: a multi-site prevalence and incidence survey in the Netherlands. PLoS One. 2014;9(3):e91029.PubMedPubMedCentralCrossRef
7.
Achim AM, Maziade M, Raymond E, Olivier D, Merette C, Roy MA. How prevalent are anxiety disorders in schizophrenia? A meta-analysis and critical review on a significant association. Schizophr Bull. 2011;37(4):811–21.PubMedCrossRef
8.
de Bont PA, van den Berg DP, van der Vleugel BM, de Roos C, de Jongh A, van der Gaag M, et al. Predictive validity of the Trauma Screening Questionnaire in detecting post-traumatic stress disorder in patients with psychotic disorders. Br J Psychiatry. 2015;206(5):408–16.PubMedCrossRef
9.
Mueser KT, Rosenberg SD, Goodman LA, Trumbetta SL. Trauma PTSD and the course of severe mental illness: an interactive model. Schizophr Res. 2002;53:123–43.PubMedCrossRef
10.
Alsawy S, Wood L, Taylor PJ, Morrison AP. Psychotic experiences and PTSD: exploring associations in a population survey. Psychol Med. 2015;45(13):2849–59.PubMedCrossRef
11.
Hamner MB, Frueh BC, Ulmer HG. Psychotic features in chronic posttraumatic stress disorder and schizophrenia: comparative severity. J Nerv Ment Dis. 2000;188(4):217–21.PubMedCrossRef
12.
OConghaile A, DeLisi LE. Distinguishing schizophrenia from posttraumatic stress disorder with psychosis. Curr Opin Psychiatry. 2015;28(3):249–55.PubMedCrossRef
13.
Brand RM, McEnery C, Rossell S, Bendall S, Thomas N. Do trauma-focussed psychological interventions have an effect on psychotic symptoms? A systematic review and meta-analysis. Schizophr Res. 2018;195:13–22.PubMedCrossRef
14.
Mueser KT, Rosenberg SD, Jankowski MK, Hamblen JL, Monica D. A cognitive-behavioral treatment program for posttraumatic stress disorder in persons with severe mental illness. Am J Psychiatr Rehabil. 2004;7:107–46.CrossRef
15.
Mueser KT, Rosenberg SD, Xie H, Jankowski MK, Bolton EE, Lu W, et al. A randomized controlled trial of cognitive-behavioral treatment for posttraumatic stress disorder in severe mental illness. J Consult Clin Psychol. 2008;76(2):259–71.PubMedPubMedCentralCrossRef
16.
Mueser KT, Gottlieb JD, Xie H, Lu W, Yanos PT, Rosenberg SD, et al. Evaluation of cognitive restructuring for post-traumatic stress disorder in people with severe mental illness. Br J Psychiatry. 2015;206(6):501–8.PubMedPubMedCentralCrossRef
17.
Steel C, Hardy A, Smith B, Wykes T, Rose S, Enright S, et al. Cognitive-behaviour therapy for post-traumatic stress in schizophrenia. A randomized controlled trial. Psychol Med. 2017;47(1):43–51.PubMedCrossRef
18.
Frueh BC, Grubaugh AL, Cusack KJ, Kimble MO, Elhai JD, Knapp RG. Exposure-based cognitive-behavioral treatment of PTSD in adults with schizophrenia or schizoaffective disorder: a pilot study. J Anxiety Disord. 2009;23(5):665–75.PubMedPubMedCentralCrossRef
19.
de Bont PA, van Minnen A, de Jongh A. Treating PTSD in patients with psychosis: a within-group controlled feasibility study examining the efficacy and safety of evidence-based PE and EMDR protocols. Behav Ther. 2013;44(4):717–30.PubMedCrossRef
20.
van den Berg DP, van der Gaag M. Treating trauma in psychosis with EMDR: a pilot study. J Behav Ther Exp Psychiatry. 2012;43(1):664–71.PubMedCrossRef
21.
van den Berg DP, de Bont PA, van der Vleugel BM, de Roos C, de Jongh A, Van Minnen A, et al. Prolonged exposure vs eye movement desensitization and reprocessing vs waiting list for posttraumatic stress disorder in patients with a psychotic disorder: a randomized clinical trial. JAMA Psychiatry. 2015;72(3):259–67.PubMedCrossRef
22.
de Bont PA, van den Berg DP, van der Vleugel BM, de Roos C, de Jongh A, van der Gaag M, et al. Prolonged exposure and EMDR for PTSD v. a PTSD waiting-list condition: effects on symptoms of psychosis, depression and social functioning in patients with chronic psychotic disorders. Psychol Med. 2016;46(11):2411–21.PubMedCrossRef
23.
van den Berg D, de Bont P, van der Vleugel BM, de Roos C, de Jongh A, van Minnen A, et al. Long-term outcomes of trauma-focused treatment in psychosis. Br J Psychiatry. 2018;212(3):180–2.PubMedCrossRef
24.
Foa EB, Hembree EA, Cahill SP, Rauch SA, Riggs DS, Feeny NC, et al. Randomized trial of prolonged exposure for posttraumatic stress disorder with and without cognitive restructuring: outcome at academic and community clinics. J Consult Clin Psychol. 2005;73(5):953–64.PubMedCrossRef
25.
van den Berg DPG, van der Vleugel BM, de Bont PAJM, Staring ABP, Kraan T, Ising H, et al. Predicting trauma-focused treatment outcome in psychosis. Schizophr Res. 2016;176(2-3):239–44.PubMedCrossRef
26.
Hardy A. Pathways from trauma to psychotic experiences: a theoretically informed model of posttraumatic stress in psychosis. Front Psychol. 2017;8:697.PubMedPubMedCentralCrossRef
27.
Schnyder U, Ehlers A, Elbert T, Foa EB, Gersons BP, Resick PA, et al. Psychotherapies for PTSD: what do they have in common? Eur J Psychotraumatol. 2015;6:28186.PubMedCrossRef
28.
de Bont PAJM, van der Vleugel BM, van den Berg DPG, de Roos C, Lokkerbol J, Smit F, et al. Health-economic benefits of treating trauma in psychosis. Eur J Psychotraumatol. 2019;10(1):1565032.PubMedPubMedCentralCrossRef
29.
Waller G, Evans J, Stringer H. The therapeutic alliance in the early part of cognitive-behavioral therapy for the eating disorders. Int J Eat Disord. 2012;45(1):63–9.PubMedCrossRef
30.
Lecomte T, Spidel A, Leclerc C, MacEwan GW, Greaves C, Bentall RP. Predictors and profiles of treatment non-adherence and engagement in services problems in early psychosis. Schizophr Res. 2008;102(1-3):295–302.PubMedCrossRef
31.
Hardy A, O’Driscoll C, Steel C, van der Gaag M, van den Berg D. A network analysis of post-traumatic stress and psychosis symptoms. Psychol Med. 2020;51(14):1–8.
32.
Liu G, Liang KY. Sample size calculations for studies with correlated observations. Biometrics. 1997;53(3):937–47.PubMedCrossRef
33.
Seow LSE, Ong C, Mahesh MV, Sagayadevan V, Shafie S, Chong SA, et al. A systematic review on comorbid post-traumatic stress disorder in schizophrenia. Schizophr Res. 2016;176(2-3):441–51.PubMedCrossRef
34.
Van Minnen A, Arntz A. Protocollaire behandeling van patiënten met een posttraumatische stressstoornis (PTSS). Imaginaire exposure en exposure in vivo. In: Keijsers G, Van Minnen A, Verbraak M, editors. Protocollaire behandelingen voor volwassenen met psychische klachten, vol. 1. Amsterdam: Boom; 2017. p. 311–69.
35.
Foa EB, Hembree EA, Rothbaum BO. Prolonged exposure therapy for PTSD. 1st ed. Oxford: Oxford University Press; 2007.
36.
van Veen SC, van Schie K, Wijngaards-de Meij LD, Littel M, Engelhard IM, van den Hout MA. Speed matters: relationship between speed of eye movements and modification of aversive autobiographical memories. Front Psychiatry. 2015;6:45.PubMedPubMedCentral
37.
van den Hout MA, Engelhard IM. How does EMDR work? J Exp Psychopathol. 2012;3(5):724–38.CrossRef
38.
Matthijsen SJMA, Brouwers T, van Roozendaal C, Vuister T, de Jongh A. The effect of EMDR versus EMDR 2.0 on emotionality and vividness of aversive memories in a non-clinical sample. Eur J Psychotraumatol. 2021;12(1):1–11.
39.
Shapiro F. Eye movement desensitization and reprocessing: basic principles, protocols, and procedures. New York: Guildford Press; 2001.
40.
De Jongh A, ten Broeke E. Handboek EMDR: een geprotocolleerde behandelmethode voor de gevolgen van psychotrauma. Amsterdam: Harcourt; 2003.
41.
First MB, Williams JB, Karg RS, Spitzer RL. Structured clinical interview for DSM-5—Research version (SCID-5 for DSM-5, research version; SCID-5-RV). Arlington: American Psychiatric Association; 2015.
42.
Blake DD, Weathers FW, Nagy LM, Kaloupek DG, Gusman FD, Charney DS, et al. The development of a Clinician-Administered PTSD Scale. J Trauma Stress. 1995;8(1):75–90.PubMedCrossRef
43.
Group WAW. The Alcohol Smoking and Substance Involvement Screening Test (ASSIST): development, reliability and feasibility. Addiction. 2002;97:1183–94.CrossRef
44.
Carr S, Hardy A, Fornells-Ambrojo M. The Trauma and Life Events (TALE) checklist: development of a tool for improving routine screening in people with psychosis. Eur J Psychotraumatol. 2018;9(1):1512265.PubMedPubMedCentralCrossRef
45.
Haddock G, McCarron J, Tarrier N, Faragher EB. Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychol Med. 1999;29(4):879–89.PubMedCrossRef
46.
Drake R, Haddock G, Tarrier N, Bentall R, Lewis S. The Psychotic Symptom Rating Scales (PSYRATS): their usefulness and properties in first episode psychosis. Schizophr Res. 2007;89(1-3):119–22.PubMedCrossRef
47.
Mitchell PH, Powell L, Blumenthal J, Norten J, Ironson G, Pitula CR, et al. A short social support measure for patients recovering from myocardial infarction: the ENRICHED Social Support Inventory. J Cardiopulm Rehabil Prev. 2003;23(6):389–403.CrossRef
48.
Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): development and initial psychometric evaluation. J Trauma Stress. 2015;28(6):489–98.PubMedCrossRef
49.
McDonald SD, Calhoun PS. The diagnostic accuracy of the PTSD checklist: a critical review. Clin Psychol Rev. 2010;30(8):976–87.PubMedCrossRef
50.
Cloitre M, Shevlin M, Brewin CR, Bisson JI, Roberts NP, Maercker A, et al. The International Trauma Questionnaire: development of a self-report measure of ICD-11 PTSD and complex PTSD. Acta Psychiatr Scand. 2018;138(6):536–46.PubMedCrossRef
51.
Foa EB, Ehlers A, Clark DM, Tolin DF, Orsillo SM. The Posttraumatic Cognitions Inventory (PTCI): development and validation. Psychol Assess. 1999;11:303–14.CrossRef
52.
Murray J, Ehlers A, Mayou RA. Dissociation and post-traumatic stress disorder: two prospective studies of road traffic accident survivors. Br J Psychiatry. 2002;180:363–8.PubMedCrossRef
53.
Beck AT, Steer RA, Brown GK. Manual for the Beck Depresion Inventory-II. San Antonio: Psychological Corporation; 1996.
54.
Freeman D, Loe BS, Kingdon D, Startup H, Molodynski A, Rosebrock L, et al. The revised Green et al., Paranoid Thoughts Scale (R-GPTS): psychometric properties, severity ranges, and clinical cut-offs. Psychol Med. 2019;51(2):244–53.PubMedPubMedCentralCrossRef
55.
McGahuey CA, Gelenberg AJ, Laukes CA, Moreno FA, Delgado PL, McKnight KM, et al. The Arizona Sexual Experience Scale (ASEX): reliability and validity. J Sex Marital Ther. 2000;26(1):25–40.PubMedCrossRef
56.
Sanchez DT, Crocker J, Boike KR. Doing gender in the bedroom: investing in gender norms and the sexual experience. Pers Soc Psychol Bull. 2005;31(10):1445–55.PubMedCrossRef
57.
Neil ST, Kilbride M, Pitt L, Nothard S, Welford M, Sellwood W, et al. The questionnaire about the process of recovery (QPR): a measurement tool developed in collaboration with service users. Psychosis. 2009;1(2):145–55.CrossRef
58.
Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194–200.PubMedCrossRef
59.
Hakkaart-van Roijen L, Van Straten A, Donker M, Tiemens B. Manual Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TiC-P): Institute for Medical Technology Assessment; 2002.
60.
Bouwmans C, De Jong K, Timman R, Zijlstra-Vlasveld M, Van der Feltz-Cornelis C, Tan Swan S, et al. Feasibility, reliability and validity of a questionnaire on healthcare consumption and productivity loss in patients with a psychiatric disorder (TiC-P). BMC Health Serv Res. 2013;13:217.PubMedPubMedCentralCrossRef
61.
Konig HH, Roick C, Angermeyer MC. Validity of the EQ-5D in assessing and valuing health status in patients with schizophrenic, schizotypal or delusional disorders. Eur Psychiatry. 2007;22(3):177–87.PubMedCrossRef
62.
63.
Corrigan JD, Schmidt LD. Development and validation of revisions in the counselor rating form. J Couns Psychol. 1983;30(1):64–75.CrossRef
64.
Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: a systematic review of empirical tests. Soc Sci Med. 2022;292:114523.PubMedCrossRef
65.
Weathers FW, Keane TM, Davidson JR. Clinician-administered PTSD scale: a review of the first ten years of research. Depress Anxiety. 2001;13(3):132–56.PubMedCrossRef
66.
Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, et al. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): development and initial psychometric evaluation in military veterans. Psychol Assess. 2018;30(3):383–95.PubMedCrossRef
67.
Boeschoten MA, Van der Aa N, Bakker A, Ter Heide FJJ, Hoofwijk MC, Jongedijk RA, et al. Development and evaluation of the Dutch Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Eur J Psychotraumatol. 2018;9(1):1546085.PubMedPubMedCentralCrossRef
68.
Hyland P, Shevlin M, Brewin CR, Cloitre M, Downes AJ, Jumbe S, et al. Validation of post-traumatic stress disorder (PTSD) and complex PTSD using the International Trauma Questionnaire. Acta Psychiatr Scand. 2017;136(3):313–22.PubMedCrossRef
69.
Wells SY, Morland LA, Torres EM, Kloezeman K, Mackintosh MA, Aarons GA. The development of a brief version of the Posttraumatic Cognitions Inventory (PTCI-9). Assessment. 2019;26(2):193–208.PubMedCrossRef
70.
Bernstein EM, Putnam FW. Development, reliability, and validity of a dissociation scale. J Nerv Ment Dis. 1986;174(12):727–35.PubMedCrossRef
71.
Marmar CR, Weiss DS, Schlenger WE, Fairbank JA, Jordan BK, Kulka RA, et al. Peritraumatic dissociation and posttraumatic stress in male Vietnam theater veterans. Am J Psychiatry. 1994;151(6):902–7.PubMedCrossRef
72.
Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996;67(3):588–97.PubMedCrossRef
73.
74.
Fowler D, Hodgekins J, Painter M, Reilly T, Crane C, Macmillan I, et al. Cognitive behaviour therapy for improving social recovery in psychosis: a report from the ISREP MRC Trial Platform Study (Improving Social Recovery in Early Psychosis). Psychol Med. 2009;39(10):1627–36.PubMedCrossRef
75.
Short S. Review of the UK 2000 time use survey. London: Office for National Statistics; 2006.
76.
de Bont PA, van den Berg DP, van der Vleugel BM, de Roos C, Mulder CL, Becker ES, et al. A multi-site single blind clinical study to compare the effects of prolonged exposure, eye movement desensitization and reprocessing and waiting list on patients with a current diagnosis of psychosis and co morbid post traumatic stress disorder: study protocol for the randomized controlled trial Treating Trauma in Psychosis. Trials. 2013;14:151.PubMedPubMedCentralCrossRef
77.
van den Berg DP, de Bont PA, van der Vleugel BM, de Roos C, de Jongh A, van Minnen A, et al. Trauma-focused treatment in PTSD patients with psychosis: symptom exacerbation, adverse events, and revictimization. Schizophr Bull. 2016;42(3):693–702.PubMedCrossRef
78.
79.
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3:77–101.CrossRef
80.
Braun V, Clarke V. Successful qualitative research: a practical guide for beginners. London: Sage; 2003.
81.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.PubMedPubMedCentralCrossRef
82.
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.PubMedPubMedCentralCrossRef
83.
Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374:n2061.PubMedPubMedCentralCrossRef
Metadata
Title
Trauma-focused therapies for post-traumatic stress in psychosis: study protocol for the RE.PROCESS randomized controlled trial
Authors
Simone R. Burger
Tineke van der Linden
Amy Hardy
Paul de Bont
Berber van der Vleugel
Anton B. P. Staring
Carlijn de Roos
Catherine van Zelst
Jennifer D. Gottlieb
Kim T. Mueser
Agnes van Minnen
Ad de Jongh
Machteld Marcelis
Mark van der Gaag
David van den Berg
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06808-6

Other articles of this Issue 1/2022

Trials 1/2022 Go to the issue

Study protocol

Effect of acupuncture for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized clinical trial

Study protocol

Use of a real-time risk-prediction model to identify pediatric patients at risk for thromboembolic events: study protocol for the Children’s Likelihood Of Thrombosis (CLOT) trial

Study protocol

Effect of perioperative cognitive behavioural therapy on chronic post-surgical pain among breast cancer patients with high pain catastrophising characteristics: protocol for a double-blinded randomised controlled trial

Study protocol

Safety, reactogenicity, and immunogenicity of a 2-dose Ebola vaccine regimen of Ad26.ZEBOV followed by MVA-BN-Filo in healthy adult pregnant women: study protocol for a phase 3 open-label randomized controlled trial

Research

Developing a theoretically informed education programme within the context of a complex implementation strategy in UK primary care: an exemplar from the IMP2ART trial

Commentary

Conducting a randomised controlled trial of a psychosocial intervention for adolescents with type 1 diabetes during COVID-19: recommendations to overcome the challenges complicated by inconsistent public health guidelines on research